Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201312000722390 Date of Approval: 09/12/2013
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Sisters Antiretroviral therapy Programme for Prevention of HIV ¿ an Integrated Response (SAPPH-IRe)
Official scientific title ANTIRETROVIRALS FOR HIV PREVENTION AND TREATMENT AMONG ZIMBABWEAN SEX WORKERS
Brief summary describing the background and objectives of the trial Using a matched pair cluster-randomized trial design, SAPPHIRe seeks to simultaneously enhance HIV treatment and prevention among highway-based sex workers by enhancing the existing targeted services to increase the uptake and frequency of HIV testing, demonstrate acceptability and feasibility of delivering FTC/TDF pre-exposure prophylaxis (PrEP) to HIV-negative sex workers, maximize retention in care of HIV-infected women currently ineligible for antiretroviral therapy (ART), promote timely initiation of ART for those eligible, and maximize adherence to both ART and PrEP, thereby establishing a positive foundation for future engagement with medical services. We hypothesize that our targeted and dedicated approach to the delivery and support of HIV testing, PrEP and ART will reduce the proportion of sex workers who are infectious with HIV in comparison with the current WHO-guideline standard services offered to sex workers with referral to government ART clinics. This effect will come about through decreasing incident HIV infection, time before HIV-infected SWs are diagnosed, and time to initiation of ART, and by increasing adherence and retention in care. We also hypothesize that this impact on viral load among the SW community will decrease the rate of transmission of HIV between sex workers and their clients and ultimately have an impact on the general population. We hypothesize that this enhanced, targeted approach for SW will be highly cost-effective by improving the health of sex workers and averting new HIV transmissions.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) SAPPHIRe
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied HIV/AIDS
Purpose of the trial Prevention
Anticipated trial start date 30/09/2013
Actual trial start date 14/11/2013
Anticipated date of last follow up 30/06/2016
Actual Last follow-up date
Anticipated target sample size (number of participants) 2800
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Cluster randomsied trial with randomisation using restricted randomisation Not applicable Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Enhanced ART for prevention intervention 1 day/wk 2 years Usual care plus onsite ART and PrEP, regular HTC, active followup supported by community mobilisation 7 Dose Comparison
Control Group Usual Care 1/week 2 years HIV prevention for SWs - HTC, STI syndromic management, contraception, condoms, health education, cervical cancer screening, legal support, community mobilisation 7 Dose Comparison
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
¿Age 18 or older ¿Currently working as a sex worker (has exchanged sex for money in the past 30 days) ¿Living or working in the study site (for at least 6 month) ¿ Under 18 ¿ Already participated in the current round of survey ¿Visiting the study site temporarily (for less than 6 month) ¿Not currently working as a sex worker (verification questions will be used to prevent fraudulent participation, such as about how sex work is organised in the area and the cost of different sex acts) 18 Year(s) 199 Year(s) Female
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 08/11/2013 Medical Research Council of Zimbabwe
Ethics Committee Address
Street address City Postal code Country
Josiah Tongogarra/Mazoe St, Harare Harare Zimbabwe
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Proportion of all SW (including those HIV-negative) who are infectious with HIV (HIV infected and viral load > 1000 copies/mL) Baseline 21 months
Secondary Outcome Proportion of HIV-infected women who are infectious Baseline 21 months
Secondary Outcome ii. Proportion of those taking ART who have viral load >1000 who have drug resistance Baseline 21 months
Secondary Outcome Incidence of HIV infection in the 6 month period before the endline survey 21 months
Secondary Outcome Proportion adherence to ART for treatment 48 weeks
Secondary Outcome Self-reported quality of life, psychological health and functioning Baseline 21 months
Secondary Outcome Proportion of SWs always using condoms with clients in last month Baseline 21 months
Secondary Outcome Proportion of SWs who know HIV status (ie are diagnosed HIV positive or were tested HIV negative in last 6 months) Baseline 21 months
Secondary Outcome Proportion of sex workers offered, initiating and, where appropriate, adhering to ART Baseline 21 months
Secondary Outcome Proportion of sex workers offered, initiating and, where appropriate, adhering to PrEP Baseline 21 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Sisters Clinic Kadoma General Hospital Kadoma Zimbabwe
Sisters Clinic Chivhu Clinic Chivhu Zimbabwe
Sisters Clinic Marondera General Hospital Marondera Zimbabwe
Sisters Clinic Chipinge General Hospital Chipinge Zimbabwe
Sisters Clinic Mandawa Hall Zvishavane Zimbabwe
Sisters Clinic Chiwaridzo Clinic Bindura Zimbabwe
Sisters Clinic Ngundu Clinic Ngundu Halt Zimbabwe
Sisters Clinic Gutu Rural District Hospital Gutu Zimbabwe
Sisters Clinic Juru Clinic Juru Zimbabwe
Sisters Clinic Chinhoyi Clinic Chinhoyi Zimbabwe
Sisters Clinic Nyamhunga Clinic Kariba Zimbabwe
Sisters Clinic Hwange Clinic Hwange Zimbabwe
Sisters Clinic Gwanda Clinic Gwanda Zimbabwe
Sisters Clinic MAgunje Rural District Hospital Magunje Zimbabwe
FUNDING SOURCES
Name of source Street address City Postal code Country
UNFPA Norfolk Road Harare Zimbabwe
DfID Zimbabwe Norfolk Road Harare Zimbabwe
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Centre for Sexual Health and HIV/AIDS Research Zimbabwe 9 Monmouth Road Harare Zimbabwe Commercial Sector/Industry
COLLABORATORS
Name Street address City Postal code Country
University College London Gower Street London WC1E6AU United Kingdom
London School of Hygiene and Tropical Medicine Keppel Street London WC1 United Kingdom
RTI San Francisco United States of America
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Frances Cowan f.cowan@ucl.ac.uk +263 772 257949 9 Monmouth Road
City Postal code Country Position/Affiliation
Avondale, Harare Zimbabwe Director
Role Name Email Phone Street address
Public Enquiries Sibongile Mtetwa sibo@ceshhar.co.zw +263 772 288169 9 Monmouth Road
City Postal code Country Position/Affiliation
Avondale, Harare Zimbabwe Project Director
Role Name Email Phone Street address
Scientific Enquiries Frances Cowan f.cowan@ucl.ac.uk +263 772 257949 9 Monmouth Road
City Postal code Country Position/Affiliation
Avondale, Harare Zimbabwe Director
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information